Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001138673
Ethics application status
Approved
Date submitted
15/10/2014
Date registered
27/10/2014
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Long-term outcomes of direct percutaneous endoscopic jejunostomy: a 10-year cohort.
Scientific title
Direct percutaneous endoscopic jejunostomy patients assessed over 10 years for clinical outcomes.
Secondary ID [1] 285500 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia 293289 0
Gastroparesis with recurrent aspiration 293292 0
Condition category
Condition code
Oral and Gastrointestinal 293561 293561 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 293610 293610 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All direct percutaneous endoscopic jejunostomy (DPEJs) were performed by two experienced interventional endoscopists (MS and NN), using a paediatric colonoscope (Olympus, GHG180) and a standard Ponsky PEG kit. All subjects received prophylactic antibiotic 1 hour prior to the procedure (Cephazolin 1gm IV; or Vancomycin 1gm IV if known to have penicillin allergy). The scope was advanced into the jejunum as far as possible. With the room light dimmed, the abdomen was closely observed for the light trans-lumination from the scope tip as the scope slowly withdrew. Once good light trans-lumination was identified, the overlying skin was quickly cleansed with local anti-septic and a 22G needle was used to puncture into the lumen of the jejunal loop under direct endoscopic vision. This is to temporarily fix and secure the relevant jejunal loop to the abdomen wall, allowing time for injection of local anaesthesia (lignocaine 2%, 10ml), insertion of a larger bore trocar needle and a small skin incision. A plastic loop-wire was then feed through the trocar needle, which was grasped by a snare and pulled out of the mouth by removing the scope. The PEG tube was attached to the loop-wire, pulled through the mouth into the jejunum and out the abdominal wall at the DPEJ site. The inner bumper was retracted against the anterior abdominal wall and fixed by a plastic disc. The procedure lasts for up to an hour. The overall duration of observation for each patient was up to 10 years.
Intervention code [1] 290440 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293375 0
Rates of technical success - measured by the success of insertion of DJEP
Timepoint [1] 293375 0
On completion of procedure
Primary outcome [2] 293376 0
Short-term complications - from consultation or monitoring of patient medical recrds.
Peri-operative (30-day) complications included gastric perforation, peri-stomal infection, leakage around the stoma, minor bleeding requiring no intervention and aspiration. In the case of gastric perforation, the gastric perforation will closed at laparotomy and the jejunostomy secured. Procedural or peri-operative related deaths will also be recorded.
Timepoint [2] 293376 0
At 30 Days post procedure
Primary outcome [3] 293377 0
Long-term complications - From any further consultations and also from medical records
Successfull enteral feeding will be measured by evidence of weight gain measured at 3 months. Intermittent regurgitation and intestinal perforation requiring surgery will also be recorded.
Timepoint [3] 293377 0
At 6 Months post procedure
Secondary outcome [1] 310888 0
Long-term Clinical success - measured by improvement in underlying diseases and the removal of the DJEP
Timepoint [1] 310888 0
Up to 10 years post procedure, measured every two years after the first 12 months

Eligibility
Key inclusion criteria
Patients who were referred for DJEP insertion between 2003 and 2013 at the Gastrointestinal Investigation Unit of the Royal Adelaide Hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for DPEJ placement included ascites, peritonitis, peritoneal carcinosis, coagulation disorders (prothrombin time of less than 50%; thrombocytes less than 50x109/L) and inability to give consent.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2003
Actual
12/08/2003
Date of last participant enrolment
Anticipated
Actual
24/10/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
83
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3049 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8821 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 290099 0
Hospital
Name [1] 290099 0
Royal Adelaide Hospital
Country [1] 290099 0
Australia
Primary sponsor type
Individual
Name
Nam Q Nguyen
Address
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 288805 0
None
Name [1] 288805 0
Address [1] 288805 0
Country [1] 288805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291807 0
Royal Adelaide Hospital Research Ethics Comittee
Ethics committee address [1] 291807 0
Ethics committee country [1] 291807 0
Australia
Date submitted for ethics approval [1] 291807 0
Approval date [1] 291807 0
01/08/2003
Ethics approval number [1] 291807 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52110 0
A/Prof Nam Q Nguyen
Address 52110 0
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital,
North Terrace, Adelaide,
South Australia 5000
Country 52110 0
Australia
Phone 52110 0
+61 8 8222 4000
Fax 52110 0
Email 52110 0
[email protected]
Contact person for public queries
Name 52111 0
Nam Q Nguyen
Address 52111 0
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital,
North Terrace, Adelaide,
South Australia 5000
Country 52111 0
Australia
Phone 52111 0
+61 8 8222 4000
Fax 52111 0
Email 52111 0
[email protected]
Contact person for scientific queries
Name 52112 0
Nam Q Nguyen
Address 52112 0
Department of Gastroenterology and Hepatology
Royal Adelaide Hospital,
North Terrace, Adelaide,
South Australia 5000
Country 52112 0
Australia
Phone 52112 0
+61 8 8222 4000
Fax 52112 0
Email 52112 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.